FDA launches GIVE to streamline generic drug approval process

October 9, 2007

FDA launches initiative to bolster generic drug program

The FDA recently held a press teleconference to announce the Generic Initiative for Value and Efficiency (GIVE) program, aimed at increasing the number and variety of generic drug products available to consumers and healthcare providers. Noting that FDA approved or tentatively approved a record 682 generic drug products in fiscal year 2007, representing a 33% increase from the previous year, FDA commissioner Andrew C. von Eschenbach said that the agency is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. The FDA also plans to hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. There are currently 1,300 drugs in backlog. The agency received 800 generic drug applications last year. The average approval time has been 16 to 17 months.

Commenting on the FDA's announcement, Generic Pharmaceutical Association president/CEO Kathleen Jaeger said, "While we all share the goal of increasing efficiency in the generic approval system, another initiative in name only simply will not get the job done. What consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics. These core issues have been around for more than a decade and include the citizen petition process, scientific consults, enhanced communication, core inspection resources, accountability and structure of the Office of Generic Drug Program."

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